Package leaflet: Information for the patient

PACKAGE LEAFLET 55 Package leaflet: Information for the patient Triveram 10mg/5mg/5mg film-coated tablets Triveram 20mg/5mg/5mg film-coated tablets...
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PACKAGE LEAFLET

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Package leaflet: Information for the patient Triveram 10mg/5mg/5mg film-coated tablets Triveram 20mg/5mg/5mg film-coated tablets Triveram 20mg/10mg/5mg film-coated tablets Triveram 20mg/10mg/10mg film-coated tablets Triveram 40mg/10mg/10mg film-coated tablets atorvastatin / perindopril arginine / amlodipine Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. 2. 3. 4. 5. 6.

What Triveram is and what it is used for What you need to know before you take Triveram How to take Triveram Possible side effects How to store Triveram Contents of the pack and other information

1.

What Triveram is and what it is used for

Triveram contains three active ingredients, atorvastatin, perindopril arginine and amlodipine in one tablet. Atorvastatin belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines. Perindopril arginine is an angiotensin converting enzyme (ACE) inhibitor. In patients with high blood pressure, it works by widening the blood vessels, which makes it easier for your heart to pump blood through them. Amlodipine belongs to a group of medicines called calcium antagonists. In patients with high blood pressure it works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina (which causes chest pain), it works by improving blood supply to the heart muscle which then receives more oxygen and as a result chest pain is prevented. Triveram is used to treat high blood pressure (hypertension) and/or stable coronary artery disease (a condition where the blood supply to the heart is reduced or blocked) in adults who also suffer from one of the following conditions: - Elevated cholesterol levels (primary hypercholesterolaemia), or - Elevated cholesterol and fat (triglyceride) levels at the same time (combined or mixed hyperlipidaemia). Triveram is intended for patients already on treatment with atorvastatin, perindopril arginine and amlodipine as single tablets. Instead of taking atorvastatin, perindopril arginine and amlodipine as single tablets you will receive one tablet of Triveram which contains the three active ingredients in the same strength.

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2.

What you need to know before you take Triveram

Do not take Triveram: if you are allergic to atorvastatin or any other statin, to perindopril or any other ACE inhibitor, to amlodipine or any other calcium antagonist, or to any of the other ingredients of this medicine (listed in section 6), if you have a disease which affects the liver, if you have had any unexplained abnormal blood tests for liver function, if you have severe low blood pressure (hypotension), if you have a cardiogenic shock (a condition where your heart is unable to supply enough blood to the body), if you have a blockage of the blood flow from the left ventricle of the heart (e.g. hypertropic obstructive cardiomyopathy and high grade aortic stenosis), if you suffer from heart failure after a heart attack, if you have experienced symptoms such as wheezing, swelling of the face, tongue or throat, intense itching or severe skin rashes with previous ACE inhibitor treatment or if you or a member of your family have had these symptoms in any other circumstances (a condition called angioedema), if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren), if you are pregnant or trying to become pregnant, or if you are a woman able to have children and not using reliable contraception, if you are breast-feeding. Warnings and precautions Talk to your doctor or pharmacist before taking Triveram if you: have a liver problem or a history of liver disease, have moderate to severe kidney problems, regularly drink a large amount of alcohol, have had repeated or unexplained muscle aches or pains, a personal history or family history of muscle problems, have or close family member have a muscle problem which runs in the family, have had previous muscular problems during treatment with other lipid-lowering medicines (e.g. other ‘-statin’ or ‘-fibrate’ medicines), have an under-active thyroid gland (hypothyroidism), have a condition or situation leading to increased levels of atorvastatin in your blood, are developing symptoms of severe respiratory failure while under treatment, have diabetes (high blood glucose), have heart failure or any other heart problem, have or have had a recent heart attack, have recently suffered from diarrhoea or vomiting, or are dehydrated, have non-severe aortic ormitral valve stenosis (narrowing of the main blood vessel leading from the heart or the mitral valve of the heart) have kidney problems; recently underwent a kidney transplantation or if you are receiving dialysis, are elderly, are experiencing a severe allergic reaction with swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing (angioedema). This may occur at any time during treatment. If you develop such symptoms, you should stop taking Triveram and see a doctor immediately, are of black origin since you may have a higher risk of angioedema and this medicine may be less effective in lowering your blood pressure than in non-black patients, are to undergo LDL apheresis (which is removal of cholesterol from your blood by a machine), are going to have desensitisation treatment to reduce the effects of an allergy to bee or wasp stings, are to undergo anaesthesia and/or major surgery, suffer from a collagen vascular disease (disease of the connective tissue) such as systemic lupus erythematosus or scleroderma, are on a salt restricted diet or use salt substitutes which contain potassium, have been told by your doctor that you have an intolerance to some sugars, are taking any of the following medicines used to treat high blood pressure: 57

- an angiotensin II receptor blocker (ARBs) (also known as sartans - for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems. - aliskiren If any of the above applies to you, consult your doctor before or while taking Triveram. Your doctor may need to carry out a blood test during your treatment to check your muscles (see Section 2 “Other medicines and Triveram”). Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional tests and medicines might be needed to diagnose and treat this. Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also information under the heading “Do not take Triveram”. While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fat in your blood, are overweight and have high blood pressure. Children and adolescents Triveram is not recommended for use in children and adolescents younger than 18 years. Other medicines and Triveram Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. There are some medicines that may change the effect of Triveram or their effect may be changed by Triveram. This type of interaction could make one or both of the medicines less effective. Alternatively it could increase the risk or severity of side-effects, including the muscle wasting condition known as rhabdomyolysis described in Section 4. Make sure to tell your doctor if you are taking any of the following medicines: immunosuppressants (medicines which reduce the defence mechanism of the body) used for the treatment of auto-immune disorders or following transplant surgery (e.g. ciclosporine, tacrolimus), ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (anti-fungal medicines), rifampicin, erythromycin, clarithromycin, telithromycin, fusidic acid, trimethoprim (antibiotics for infection caused by bacteria), Colchicine (used in the treatment of gout, a disease with painful, swollen joints caused by uric acid crystals), other medicines to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol, ezetimibe, some calcium channel blockers used for angina or high blood pressure, e.g. diltiazem, medicines to regulate your heart rhythm e.g. digoxin, verapamil, amiodarone, medicines used in the treatment of HIV e.g. delavirdine, efavirenz, ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc., warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anti-convulsant for epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a painkiller), antacids (indigestion products containing aluminium or magnesium), medicine obtained without a prescription: hypericum perforatum or St John’s Wort (herbal treatment used for depression), dantrolene (infusion for severe body temperature abnormalities), other medicines for high blood pressure, including aliskiren, angiotensin II receptor blockers (e.g. valsartan) see also information under the headings “Do not take Triveram” and “Warnings and precautions”), potassium-sparing drugs (e.g. triamterene, amiloride, eplerenone, spironolactone), potassium supplements or potassium-containing salt substitutes, estramustine (used in cancer therapy), lithium for mania or depression, 58

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medicines to treat diabetes (such as insulin, metformin or gliptines), baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis), non-steroidal anti-inflammatory drugs (e.g. ibuprofen) for pain relief or treatment of inflammation (e.g. in case of rheumatoid arthritis) or high dose aspirin, vasodilators including nitrates (products that make the blood vessels become wider), heparin (medicines used to thin blood), medicines to treat mental disorders such as depression, anxiety, schizophrenia etc (e.g. tricyclic antidepressants, antipsychotics), medicines used for the treatment of low blood pressure, shock or asthma (e.g. ephedrine, noradrenaline or adrenaline), gold salts, especially with intravenous administration (used to treat symptoms of rheumatoid arthritis), allopurinol (for the treatment of gout), procainamide (for the treatment of an irregular heart beat).

Triveram with food, drink and alcohol It is preferable to take Triveram before a meal. Grapefruit and grapefruit juice Grapefruit juice and grapefruit should not be consumed by people who are taking Triveram. This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Triveram. If you are taking Triveram, you should not take more than one or two small glasses of grapefruit juice per day because large quantities of grapefruit juice will lead to an increased effect of the active ingredient atorvastatin. Alcohol Avoid drinking too much alcohol while taking this medicine. See Section 2 “Warnings and precautions” for details. Pregnancy Do not take Triveram if you are pregnant, if you are trying to become pregnant or if able to become pregnant unless you use reliable contraceptive measures (see “Do not take Triveram”). If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. This medicine must not be used during pregnancy. Breast-feeding You must not take Triveram if you are breast-feeding. Tell your doctor immediately if you are breast-feeding or about to start breast-feeding. Driving and using machines Triveram may cause dizziness, headache, fatigue or nausea. If you are affected in this way, your ability to drive or to operate machinery may be impaired, especially at the start of the treatment. Triveram contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 3.

How to take Triveram

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is one tablet per day. Swallow your tablet with a glass of water preferably at the same time each day, in the morning before a meal. 59

Use in children and adolescents Triveram is not recommended for use in children and adolescents younger than 18 years. If you take more Triveram than you should If you take more tablets than prescribed, contact your nearest accident and emergency department or tell your doctor immediately. Taking too many tablets may cause your blood pressure to become low or even dangerously low. It can make you feel dizzy, lightheaded, faint or weak. If this happens, lying down with the legs raised can help. If blood pressure drop is severe enough shock can occur. Your skin could feel cool and clammy and you could lose consciousness. If you forget to take Triveram It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Triveram, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose. If you stop taking Triveram As the treatment with Triveram is usually life-long, you should discuss with your doctor before stopping this medicinal product. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking the medicinal product and see a doctor immediately, if you experience any of the following side effects that can be serious: swelling of eyelids, the face, lips, mouth, tongue or throat, difficulty in breathing (angioedema) (uncommon, may affect up to 1 in 100 people) (See section 2 “Warnings and precautions”), severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens Johnson Syndrome) or other allergic reactions (rare, may affect up to 1 in 1,000 people.), muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown which can be life-threatening and lead to kidney problems (rare, may affect up to 1 in 1,000 people), weakness of arms or legs, or problems speaking which could be a sign of a possible stroke (Very rare may affect up to 1 in 10,000 people), severe dizziness (common, may affect up to 1 in 10 people) or fainting (uncommon, may affect up to 1 in 100 people) due to low blood pressure, unusual fast or irregular heart-beat (uncommon, may affect up to 1 in 100 people), chest pain (angina) or heart attack (very rare, may affect up to 1 in 10,000 people), sudden wheeziness, chest pain, shortness of breath, or difficulty in breathing (bronchospasm) (Uncommon - may affect up to 1 in 100 people), inflamed pancreas which may cause severe abdominal and back pain accompanied with feeling very unwell (uncommon, may affect up to 1 in 100 people), if you experience problems with unexpected or unusual bleeding or bruising, this may be suggestive of a liver complaint (very rare, may affect less than 1 in 10,000 people), yellowing of the skin or eyes (jaundice) which could be a sign of hepatitis (Very rare - may affect up to 1 in 10,000 people), skin rash which often starts with red itchy patches on your face, arms or legs (erythema multiforme) (Very rare - may affect up to 1 in 10,000 people). Tell your doctor if you notice any of the following side effects: Very common (may affect more than 1 in 10 people): - oedema (fluid retention) 60

Common (may affect up to 1 in 10 people): -

inflammation of the nasal passages, pain in the throat, nose bleed allergic reactions (such as skin rashes, itching) increases in blood sugar levels (if you have diabetes continue careful monitoring of your blood sugar levels), increase in blood creatine kinase headache, dizziness, vertigo, pins and needles, feeling of tiredness vision impairment, double vision, tinnitus (sensation of noises or ringing in the ears) cough, shortness of breath (dyspnoea) gastro-intestinal disorders: feeling sick (nausea), being sick (vomiting), constipation, wind, indigestion, change of bowel habit, diarrhoea, abdominal pain, taste disturbances, dyspepsia joint pain, muscle pain, muscle spasms and back pain fatigue, weakness, ankle swelling , palpitations (awareness of your heart beat), flushing blood test results that show your liver function can become abnormal

Uncommon (may affect up to 1 in 100 people): -

anorexia (loss of appetite), weight gain or weight decrease, decreases in blood sugar levels (if you have diabetes you should continue careful monitoring of your blood sugar levels) having nightmares, insomnia, sleep disturbances, somnolence, mood altered, anxiety, depression numbness or tingling in the fingers and toes or in your limbs, reductions of sensation to pain or touch, change in sense of taste, loss of memory vision blurred low blood pressure sneezing/running nose caused by inflammation of the lining of the nose (rhinitis) belching, dry mouth, abdominal pain upper and lower intense itching or severe skin rashes, red patches on skin, skin discoloration, formation of blister clusters over the skin, hives, photosensitivity reaction (increased sensitivity of the skin to sun), hair loss kidney problems, disorder in passing urine, increased need to urinate at night, increased number of times of passing urine inability to obtain an erection, impotence, discomfort or enlargement of the breasts in men neck pain, muscle fatigue feeling unwell, trembling, fainting, fall, chest pain, malaise, raised temperature (fever), increased sweating, pain tachycardia (fast heart beat), vasculitis (inflammation of blood vessels) excess of eosinophils (a type of white blood cells) urine tests that are positive for white blood cells change in laboratory parameters: high blood level of potassium reversible on discontinuation, low level of sodium, hypoglycaemia (very low blood sugar level) in case of diabetic patients, increased blood urea, and increased blood creatinine

Rare (may affect up to 1 in 1,000 people): -

confusion unexpected bleeding or bruising cholestasis (yellowing of the skin and whites of the eyes) tendon injury changes in laboratory parameters: increased level of liver enzymes, high level of serum bilirubin disorder of the nerves which can cause weakness, tingling or numbness

Very rare (may affect up to 1 in 10,000 people): -

eosinophilic pneumonia (a rare type of pneumonia) hearing loss sensitivity to light 61

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increased muscle tension swelling of the gums acute kidney failure abdominal bloating (gastritis) hepatic function abnormal, yellowing of the skin (jaundice), liver enzyme increase which may have an effect on some medical tests changes in blood values such as a lower number of white and red blood cells, lower haemoglobin, lower number of blood platelets which may result in unusual bruising or easy bleeding (red blood cell damage), illness resulting from the destruction of red blood cells

Unknown frequency muscle weakness that is constant trembling, rigid posture, mask-like face, slow movements and a shuffling, unbalanced walk.

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Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 5.

How to store Triveram

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and tablet container after EXP. Tablets are stable 10 days after opening in the 10-tablet polypropylene container (available for 10/5/5 mg strength only). Tablets are stable 30 days after opening in the 30-tablet polypropylene container. Tablets are stable 100 days after opening in the 100-tablet high density polyethylene container. The expiry date refers to the last day of that month. Keep the container tightly closed in order to protect from moisture. All strengths besides the 40/10/10 mg in tablet container with 100 tablets: No special temperature storage conditions. The 40/10/10 mg strength in tablet container with 100 tablets: Store below 30°C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.

Contents of the pack and other information

What Triveram contains The active substances are atorvastatin, perindopril arginine and amlodipine. Each tablet of Triveram 10/5/5 mg contains 10.82 mg atorvastatin calcium trihydrate equivalent to 10 mg atorvastatin, 5 mg perindopril arginine equivalent to 3.40 mg perindopril and 6.94 mg amlodipine besilate equivalent to 5 mg amlodipine Each tablet of Triveram 20/5/5 mg contains 21.64 mg atorvastatin calcium trihydrate equivalent to 20 mg atorvastatin, 5 mg perindopril arginine equivalent to 3.40 mg perindopril and 6.94 mg amlodipine besilate equivalent to 5 mg amlodipine Each tablet of Triveram 20/10/5 mg contains 21.64 mg atorvastatin calcium trihydrate equivalent to 20 mg atorvastatin, 10 mg perindopril arginine equivalent to 6.79 mg perindopril and 6.94 mg amlodipine besilate equivalent to 5 mg amlodipine Each tablet of Triveram 20/10/10 mg contains 21.64 mg atorvastatin calcium trihydrate equivalent to 20 mg atorvastatin, 10 mg perindopril arginine equivalent to 6.79 mg perindopril and 13.87 mg amlodipine besilate equivalent to 10 mg amlodipine 62

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Each tablet of Triveram 40/10/10 mg contains 43.28 mg atorvastatin calcium trihydrate equivalent to 40 mg atorvastatin, 10 mg perindopril arginine equivalent to 6.79 mg perindopril and 13.87 mg amlodipine besilate equivalent to 10 mg amlodipine.

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The other ingredients are: tablet core: lactose monohydrate, calcium carbonate (E170), hydroxypropylcellulose (E463), sodium starch glycolate (type A), microcrystalline cellulose (E460), maltodextrin, magnesium stearate (E572). tablet film-coating: glycerol (E422), hypromellose (E464), macrogol 6000, magnesium stearate (E572), titanium dioxide (E171), iron oxide yellow (E172). What Triveram looks like and contents of the pack Triveram 10/5/5 mg tablets are yellow round film-coated tablets of 7 mm diameter, with a curvature radius of 25 mm, engraved with “ ”on one face, and on the other face. Triveram 20/5/5 mg tablets are yellow round film-coated tablets of 8.8 mm diameter, with a curvature radius of 32 mm, engraved with “ ”on one face, and on the other face. Triveram 20/10/5 mg tablets are yellow square-shaped film-coated tablets of 9 mm side length, with a curvature radius of 16 mm, engraved with “ ”on one face, and on the other face. Triveram 20/10/10 mg tablets are yellow oblong-shaped film-coated tablets of 12.7 mm length and 6.35 mm width, engraved with “ ”on one face, and on the other . Triveram 40/10/10 mg tablets are yellow oblong-shaped film-coated tablets of 16 mm length and 8 mm width, engraved with “ ”on one face, and on the other face. The tablets are available in containers of 10 (available for 10/5/5 mg strength only), 30 and 100 tablets. A presentation containing 90 (3 containers of 30) tablets is also available. 30 film-coated tablets in container closed with a stopper. The stopper contains a desiccant. 100 film-coated tablets in container with a screwcap. The screwcap contains a desiccant. The tablet container contains 1-4 dessicant capsules. The desiccant capsules should not be removed nor eaten. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder For RMS (Finland): Les Laboratoires Servier 50, rue Carnot 92284 Suresnes cedex France Manufacturer Les Laboratoires Servier Industrie 905, route de Saran 45520 Gidy France and Anpharm Przedsiebiorstwo Farmaceutyczne S.A. 03-236 Warszawa ul. Annopol 6b – Poland

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and EGIS Pharmaceuticals PLC H-9900 Körmend, Mátyás király u.65 Hungary and Servier (Ireland) Industries Ltd (SII) Moneylands - Gorey Road – Arklow Co. Wicklow- Ireland This medicinal product is authorised in the Member States of the EEA under the following names: Austria Triveram Belgium Lipertance Bulgaria Lipertance Croatia Lipertance Czech Republic Lipertance Cyprus Triveram Estonia Triveram Finland Triveram France Triveram Germany Triveram Greece Triveram Hungary Triveram Ireland Triveram Italy Triveram Latvia Triveram Lithuania Triveram Luxembourg Lipertance Malta Triveram Netherlands Triveram Poland Triveram Portugal Triveram Romania Lipertance Slovakia Lipertance Slovenia Statriam This leaflet was last revised in . Detailed information on this medicine is available on the web site of {MA/Agency}>

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